drugset / Trial / NCT05659056

Neoadjuvant Study With Pyrotinib and Trastuzumab and Abraxane in Patients With HER2-enriched Breast Cancer

NCT05659056 ↗

NaSingle-groupOpen-labelTreatment

Summary

Breast cancer is kind of highly heterogeneous tumor. The patients with the same stage and with the same treatment regimen, their prognosis varies greatly, mainly due to the different phenotypes of breast cancer and different sensitivities to drug therapy. PMA50 and BluePrint classification divides breast cancer into other inherent subtypes: Luminal A, Luminal B, HER2-enriched (HER2-E) and Basal-like. Previous studies have shown that these patients with inherent subtype of HER2-enriched are more likely to obtain higher pCR after anti-HER2 therapy. And more study and meta analysis had demonstrated the higher pCR is closely related to EFS. The genetic and molecular typing of breast cancer is closely related to the prognosis of breast cancer, so it is imperative to seek a new treatment regimen for precision treatment and maximize the therapeutic benefit of HER2-enriched patients.

Timeline

Start
2022-11-29
Primary completion
2024-04
Completion
2024-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Paclitaxel Small molecule 260 mg/m2 —
Subject Pyrotinib Small molecule 400 mg Oral
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous

Indications